Description and Brand Names

US Brand Name

Dolobid

Descriptions

Diflunisalis a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

This medicine is available only with your doctor's prescription .

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diflunisal in children below 12 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diflunisal in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving diflunisal .

Pregnancy

Information about this diflunisal-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Anagrelide

Apixaban

Ardeparin

Argatroban

Beta Glucan

Bivalirudin

Certoparin

Cilostazol

Citalopram

Clomipramine

Clopidogrel

Cyclosporine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desipramine

Desirudin

Desvenlafaxine

Dibenzepin

Dipyridamole

Dothiepin

Doxepin

Duloxetine

Edoxaban

Enoxaparin

Eptifibatide

Erlotinib

Escitalopram

Feverfew

Fluoxetine

Fluvoxamine

Fondaparinux

Ginkgo

Gossypol

Heparin

Imipramine

Lepirudin

Levomilnacipran

Lofepramine

Meadowsweet

Melitracen

Methotrexate

Milnacipran

Nadroparin

Nefazodone

Nortriptyline

Opipramol

Parnaparin

Paroxetine

Pemetrexed

Pentosan Polysulfate Sodium

Pentoxifylline

Phenprocoumon

Pralatrexate

Prasugrel

Protein C

Protriptyline

Reboxetine

Reviparin

Rivaroxaban

Sertraline

Sibutramine

Tacrolimus

Tianeptine

Ticlopidine

Tinzaparin

Tirofiban

Trimipramine

Venlafaxine

Vilazodone

Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Acenocoumarol

Alacepril

Alprenolol

Amiloride

Anisindione

Arotinolol

Atenolol

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Delapril

Dicumarol

Dilevalol

Enalapril

Enalaprilat

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Labetalol

Landiolol

Levobunolol

Lisinopril

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Moexipril

Nadolol

Nebivolol

Nipradilol

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Temocapril

Tertatolol

Timolol

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Warfarin

Xipamide

Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or

Asthma or

Bleeding problems or

Blood clots or

Edema (fluid retention or body swelling) or

Heart attack, history of

Heart disease (e.g., congestive heart failure) or

High blood pressure or

Kidney disease or

Liver disease (e.g., hepatitis) or

Stomach or intestinal ulcers or bleeding or

Stroke, history of—Use with caution. This medicine may make these conditions worse .

Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Swallow the tablet whole with a full glass of water. Do not crush or chew it .

To lessen stomach upset, you may take this medicine with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For mild to moderate pain:

Adults and teenagers—1000 milligrams (mg) for the first dose, then 500 mg every eight to twelve hours as needed. Some people may need only 500 mg for the first dose, then 250 mg every eight to twelve hours as needed. Usually, no more than a total of 1500 mg a day should be taken.

Children below 12 years of age—Use and dose must be determined by your doctor .

For osteoarthritis and rheumatoid arthritis:

Adults and teenagers—At first, 250 or 500 mg twice a day. Your doctor may increase or decrease your dose as needed. However, the dose usually is not more than 1500 mg once a day.

Children below 12 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

This medicine can cause a rare but serious illness called Reye's syndrome. It occurs mostly in children and teenagers, but can affect someone at any age. Do not give this medicine to anyone who has chicken pox or symptoms of a virus or the flu, unless your doctor has told you to. If a child has behavior changes along with nausea and vomiting while using this medicine, call the doctor right away.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

red, irritated eyes

redness of the face, neck, arms and occasionally, upper chest

red skin lesions, often with a purple center

red, swollen skin

scaly skin

severe or continuing stomach pain

shortness of breath

skin rash

sores, ulcers, or white spots in mouth or on lips

sore throat

stomach upset

swelling of face, fingers, feet or lower legs

swollen lymph nodes

tenderness in stomach area

tightness in chest

troubled breathing

tunnel vision

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal pain

vomiting of blood or material that looks like coffee grounds

weight gain

wheezing

yellow eyes or skin

Symptoms of overdose

Change in consciousness

confusion about identity, place, and time

continuing ringing or buzzing or other unexplained noise in ears

decreased awareness or responsiveness

deep or fast breathing with dizziness

fast, pounding, or irregular heartbeat or pulse

hearing loss

loss of consciousness

numbness of feet, hands, and around mouth

severe sleepiness

sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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